FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
145465–145488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1986
TRANSFER NEEDLE
K854556 · LHI
Soma Intl., Inc.
General Hospital · 63d
Cleared Jan 16, 1986
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
K854560 · DXY
Telectronics, Inc.
Cardiovascular · 63d
Cleared Jan 16, 1986
SEAMED MODEL 4000
K854648 · DTE
Seamed Corp.
Cardiovascular · 58d
Cleared Jan 16, 1986
DIGITAL FASHION THERMOMETER
K854706 · FLL
Kanada Manufacturing Co., Ltd.
General Hospital · 56d
Cleared Jan 15, 1986
DIAGNOSTIC INTRAVASCULAR CATHETERS
K853182 · DQO
Mallinckrodt Critical Care
Cardiovascular · 169d
Cleared Jan 15, 1986
THE GRIPPER
K853422 · BXN
Regional Master Corp.
Anesthesiology · 154d
Cleared Jan 15, 1986
PINPOINT NEEDLE
K853478 · BSP
Regional Master Corp.
Anesthesiology · 154d
Cleared Jan 15, 1986
DNR UNIPOLAR
K853568 · DTB
Biotronik Sales, Inc.
Cardiovascular · 142d
Cleared Jan 15, 1986
NOVA ARTERIAL EMBOLECTOMY CATHETER
K853625 · DXE
Nova Medical Specialties
Cardiovascular · 139d
Cleared Jan 15, 1986
STYLET INTRODUCER FUNNEL
K854142 · DTB
Telectronics, Inc.
Cardiovascular · 96d
Cleared Jan 15, 1986
MEDSURG POTT-COURNAND NEEDLE
K854293 · DRC
Medsurg Industries, Inc.
Cardiovascular · 82d
Cleared Jan 15, 1986
CUSHION-FLEX TM-CPAP FACE MASK
K854458 · BYE
Life Design Systems, Inc.
Anesthesiology · 70d
Cleared Jan 15, 1986
ACUSON AL558 TRANSDUCER
K854785 · ITX
Acuson Computed Sonography
Radiology · 47d
Cleared Jan 15, 1986
ACUSON BL538 TRANSDUCER
K854786 · ITX
Acuson Computed Sonography
Radiology · 47d
Cleared Jan 15, 1986
ACUSON AL538 TRANSDUCER
K854788 · ITX
Acuson Computed Sonography
Radiology · 47d
Cleared Jan 15, 1986
T-4 RIASSAY
K854798 · CDX
Ria Diagnostics
Chemistry · 44d
Cleared Jan 15, 1986
ELECATH PULSATILE PERFUSION PUMP
K854975 · KFM
Electro-Catheter Corp.
Cardiovascular · 34d
Cleared Jan 14, 1986
MODEL TT-185 TELEMETRY TRANSMITTER
K851624 · DXH
Eaton Medical Group
Cardiovascular · 271d
Cleared Jan 14, 1986
CORDIS MULTICOR ST, MODEL 350A
K851968 · DXY
Cordis Corp.
Cardiovascular · 252d
Cleared Jan 14, 1986
CONFIDENT ODOR ELIMINATOR
K852471 · EXB
Hallmark Industries, Inc.
Gastroenterology & Urology · 217d
Cleared Jan 14, 1986
PALLADIUM SEED MODEL 100
K852542 · IWI
Nuclear Medicine, Inc.
Radiology · 214d
Cleared Jan 14, 1986
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
K852641 · DXY
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 208d
Cleared Jan 14, 1986
COMFORT - CUF
K852978 · DXN
Dynasty Instruments, Ltd.
Cardiovascular · 183d
Cleared Jan 14, 1986
OSM-1 OXYGEN SATURATION MONITOR
K853331 · JOM
Criticare Systems, Inc.
Cardiovascular · 159d